Samsung Bioepis applies to sell SB5 biosimilar in the U.S.Samsung Bioepis said Thursday that it has applied to sell its SB5 biosimilar in the United States.
Samsung Bioepis said the U.S. Food and Drug Administration has started its review of the application, which will pave the way for the company to sell the product in the key North American market.
SB5 is a biosimilar of Humira released by U.S.-based AbbVie and is used for the treatment of various diseases, including Crohn’s disease and rheumatoid arthritis.
Samsung Bioepis got the nod in August last year to sell SB5 in Europe, with the official launch slated to begin in October in cooperation with Biogen. Samsung Bioepis and AbbVie agreed on a patent in April, which allows the Korean company to sell SB5 in Europe starting in October this year. Sales in the United States will be allowed starting in June 2023 if it is approved.